Challenges in the codevelopment of companion diagnostics

Personalized Medicine
Mathew W MoorePhilip D Cotter

Abstract

Therapeutics harnessing the power of personalized medicine have the potential to revolutionize healthcare. Companion diagnostics are critical to this goal and are increasingly relied upon to ensure the effective, safe development and use of a personalized therapeutic. Companion diagnostics are the focus of several recent regulatory guidance documents; the drug-diagnostic codevelopment process has become increasingly relevant and necessary. Despite this, the promise of companion diagnostics has not been fully realized and there are multiple difficulties that still need resolution. The path to codevelop a successful companion diagnostic with its complementary drug is complex, fragmented and fraught with several challenges. In this article, we discuss the logistic, strategic business, regulatory and financial challenges involved in drug-companion diagnostic codevelopment.

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Citations

Sep 7, 2013·Nature Reviews. Drug Discovery·Jane FridlyandHoward I Scher
Jun 8, 2019·SLAS Technology·Mosfera A ChowduryEdmond W K Young
Nov 16, 2013·Toxicologic Pathology·Jason DeVoss, Lauri Diehl
Dec 11, 2019·The Pharmacogenomics Journal·Arun RadhakrishnanNikhitha K Shanmukhan
Dec 15, 2020·Expert Review of Molecular Diagnostics·Thomas B G PoulsenAllan Stensballe

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Methods Mentioned

BETA
PCR
genotyping

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